IBC-Standard-Operating-Procedures-Revised-3-1-19

In addition to recombinant DNA/nucleic acid, the Utah State University USU IBC reviews, approves and oversees project proposals involving biohazardous materials including BSL-2/3 infecti

Standard Operating Procedures Utah State University

Institutional Biosafety Committee

Adopted: 07.26.2018

Revised: 02.28.2019

I IBC Policies

A Scope of the IBC

The existence of an Institutional Biosafety Committee (IBC) is required by the National Institutes of Health (NIH) for research involving recombinant and synthetic nucleic acids In addition to recombinant DNA/nucleic acid, the Utah State University (USU) IBC reviews, approves and oversees project proposals involving biohazardous materials (including BSL-2/3 infectious agents), "Select

Agents" (as stated in USU's Policy 583.11: Safety and Health in Research), and

dual use of research of concern (DURC) (required under the 2015 US Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern)

The purpose of these Standard Operating Procedures (SOPs) is to provide guidance to USU personnel, including faculty, staff and members of the IBC as they carry out activities involving recombinant DNA/nucleic acid, biohazardous materials -including BSL-2/3 infectious agents and "Select Agents", and DURC at USU or under its jurisdiction

These SOPs indicate how the latest versions of the “NIH Guidelines for Research Involving Recombinant DNA Molecules”, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) (5 th edition), CDC and USDA Select Agents Regulations as well as other applicable federal, state, and local laws are to be

implemented by USU employees The NIH Guidelines are provided at the web

site of the Office of Science Policy (OSP):

https://osp.od.nih.gov/biotechnology/nih-guidelines/, and shall apply to all recombinant DNA research performed at USU, whether funded by NIH or not

The IBC shall coordinate its activities with the Office of the Vice President for Research (VPR), the Office of Research Integrity and Compliance (RIC), the Office

of Environmental Health and Safety (EH&S), the Sponsored Programs Office

(SPO), Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Chemical Hygiene Committee (CHC), Radiation Safety Committee (RSC), Risk Control Committee (RCC), and University Safety Committee, and other oversight committees of the university, to ensure that research carried out at the USU meets the high ethical standards of the institution

B IBC Authority

The IBC is a committee appointed by the Vice President for Research and authorized to independently review, approve and oversee research involving recombinant DNA/nucleic acid activities, biohazardous materials, select agents, and DURC activities The IBC shall have the authority to assess the risks

associated with undertaking covered research and, based on their findings, to approve or deny approval for such research

Research involving human participants based on the 45 CFR 46, “Common Rule”

shall require both IBC and IRB approval If the IRB requires revisions to the approved IBC protocol, the Principal Investigators (PIs) shall immediately amend the protocol No such research shall be initiated until all appropriate procedures and measures have been taken to ensure that human participants’ rights and welfare are adequately protected

The NIH Guidelines shall apply to all recombinant DNA research performed at

USU unless such research falls within categories which are exempt from the Guidelines Section I-C-1-a of the NIH Guidelines specifies that they are

applicable to “research that is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH…”

C Ensuring compliance

In accordance with NIH Guidelines Section IV-B-2-b-(5), the IBC shall annually review research involving recombinant DNA/nucleic acid at USU to ensure

compliance with NIH Guidelines Furthermore, as per Section IV-B-3-c-(1), the Biological Safety Officer shall perform periodic inspections no less than once a year to ensure laboratory standards are rigorously followed

Records of the IBC shall be retained by the Office of Environmental Health and Safety (EH&S) including but not limited to protocols, meeting agendas and minutes, and rosters of members USU requires PIs to keep copies of research records All records must be accessible for inspection and copying by authorized representatives for three years after expiration or termination of the study

D Conflict of Interest

In accordance with Section IV-B-2-a-(4) of the NIH Guidelines, members of the IBC shall not be involved in the review or approval of projects in which they hold

a direct financial interest, except to provide information requested by the IBC

No member or consultant of the IBC may review or vote on a project with the following conflicts:

1 Institutional conflict of interest

2 Conflicts of commitment

3 Individual conflicts

a) Financial b) Competing

E Responsible Official and Noncompliance

In accordance with federal regulations 9 CFR Part 121 "Possession, Use, and Transfer of Select Agents and Toxins" and 42 CFR Part 73 "Select Agents and Toxins" an individual must be designated as the responsible official who ensures compliance For USU, that individual is the Biological Safety Officer Information

concerning noncompliance with the NIH Guidelines and federal regulations on

select agents and toxins may be brought forward by any person to the Biological Safety Officer, Responsible Official, the IBC Chair, and/or the IBC Vice Chair All

studies under the purview of the IBC must comply with NIH Guidelines regarding

Noncompliance

F USU Investigators Responsibilities

All PIs shall become familiar with applicable NIH Guidelines, Center of Disease Control’s Biosafety and Microbiological and Biomedical Laboratories (BMBL),

DURC and Select Agent Regulations and shall adhere to their intent, as well as to the specific elements contained in them Further, it is the responsibility of the PI

to obtain the necessary approvals before initiating research

G Conflict of Interest for Investigators and Research Team

In accordance with USU's Policy 307.2 "University employees shall not realize personal gain in any form which improperly influences the conduct of their University duties They shall not knowingly use University property, funds, position, or power for personal or political gain, nor engage in any financial or personal activity which may disadvantage the University They shall report in writing all reasonably foreseeable conflicts Financial conflicts are to be reported via Kuali COI for review and approval All other conflicts must be reported to the RIC Director for clarification on how to proceed

H Investigator Training

Utah State University is responsible for ensuring that the PI has appropriate training, NIH Guidelines Section IV-B-1-h However, this responsibility may be delegated to the IBC or the BSO PIs shall obtain training available through the IBC, EH&S and CITI, USU's Policy 583.11

The PI is responsible for ensuring that laboratory staff are appropriately trained

in laboratory safety and implementation of NIH Guidelines They shall ascertain

that all laboratory personnel receive appropriate training to carry out their

functions safely and in a scientifically appropriate manner

I Appeal of an IBC Decision

PIs have a right to appeal IBC decisions concerning their research projects Such request for appeal of an IBC decision must be made in writing to the IBC Chair or IBC Vice Chair

J Investigator separation and data ownership

In accordance with USU's Research Policy 588.3 entitled Ownership of Data,

"OMB Uniform Guidance, Section 200.315(a) provides guidance on ownership and use of Intangible Property, including Research Data USU applies this guidance to all Research Data Therefore, title to Research Data vests in Utah State University (USU) immediately upon its acquisition USU must use Research Data for any originally-authorized purpose as outlined in any funding agreement sponsoring the Research and must not restrict access to the Research Data in contravention of Federal or other applicable regulations or contractual requirements."

Further, " Original Research Data and preliminary data collected or acquired in the conduct of Research at USU must be retained at USU, except as set forth below when the PI leaves the university When an investigator at USU leaves the University, the investigator may take copies of Research Data and other data associated with the Research when the individual’s participation in the design, conduct or reporting of the associated project can be established, and with permission from an authorized university representative

When a PI leaves USU the Department Head and/or Dean, shall determine who will take responsibility for Research Data as set forth in RGS Procedure 588-PR." (USU Research Policy #588.6 Transfer of Research Data Associated with a

Transferred Contract or Grant)

II IBC Administrator Responsibilities

As set forth by NIH Guidelines Section IV-B-2-a-(5) Utah State University may establish procedures that the IBC shall follow in its review and approval of protocols USU has delegated the following responsibility to the IBC Administrator:

 Update IBC procedures

 Oversee documentation of registration and approval process

 Oversee documentation of information requests and non-compliance incidents

 Retain documentation in an orderly and retrievable fashion

 Delete documentation after retaining for 5 years

 Maintain "IBC Registration Database"

 Create protocol registration forms for project proposals involving recombinant DNA/nucleic acid, biohazardous materials - including BSL-2/3 infectious agents and "Select Agents", dual use research of concern (DURC), annual reviews, and safety reports (adverse event)

 Oversee training of IBC members on registration forms and approval process

 Maintain documentation throughout the approval process in a designated platform (ServiceNow) Such documentation includes:

o Registration Protocols

o Questions concerning the project proposal by the IBC

o Correspondence with the PI concerning IBC questions about the project proposal

o Resolution of questions about a project proposal

o Modifications to a proposal/protocol

o Risk Mitigation Plans (DURC)

o IBC approval and annual review letters

o Safety Report (Adverse Event)

o Reviewed and approved Standard Operating Procedures (SOPs)

 Provide annual reporting to NIH In accordance with NIH Guidelines Section IV-B-2-a-(3) Utah State University shall file an annual report with NIH OSP which includes:

o A roster of all Institutional Biosafety Committee members clearly indicating the Chair, contact person, Biological Safety Officer (if applicable), plant expert (if applicable), animal expert (if

applicable), human gene therapy expertise or ad hoc consultant (if applicable)

o Biographical sketches of all Institutional Biosafety Committee members (including community members)

 Organize, record, and paraphrase IBC meetings

o Create an "Agenda" a week prior to IBC meetings

o Record IBC meetings

o Create hard copy of IBC meetings minutes

o Retain all meeting "Agendas" and "Minutes."

o Make all Agendas and Minutes available to the public upon request

 Correlate IBC and PI correspondence to NIH

o Committee members shall upload on ServiceNow or make available to the IBC Administrator any correspondence concerning

a research proposal from the approval process, designated review, and/or after committee approval that is conducted outside the designated platform

 Retain all records submitted through a designated platform (ServiceNow) by PIs to the IBC

o Original proposals and modifications

o Changes made to a research protocol following initial approval

o Written reports of any adverse event (Safety Report) NIH Guidelines Appendix M-I-C-4

 Review of submitted protocols for completeness

o Check the submitted protocol for completeness, but not content

o If incomplete, return to PI for additional information

o Send to the IBC Chair

 PI Notification of IBC determination

o Prepare a notification letter

 Approved

 Returned for clarification/additional information

o E-mail notification letter to the PI

o Upload determination to ServiceNow

III IBC Standard Operating Procedures

A Membership of the IBC

Composition of the IBC will be based on the types of research to be performed at USU The IBC will be composed of no fewer than five voting members from the USU

community with the collective experience and expertise to assess the safety of research involving biohazardous material, including an expert in plant containment principles and

an expert in animal containment principles Further description of the specific areas of expertise and associated experiments can be found in the NIH Guidelines Section

IV-B-2-a

As required by the NIH Guidelines, because USU performs research at Biosafety Level 2

and 3 (BSL-2 and BSL-3), the IBC shall include USU’s Biological Safety Officer

At least two additional members, known as "community members", shall be appointed from the local community by the VPR and cannot be affiliated with the University apart from their membership on the IBC Community members are not expected to act as primary reviewers for research proposals (NIH Guidelines Section IV-B-2-a)

The IBC may use consulting experts to execute its responsibilities or acquire needed expertise for select tasks Consultants are not IBC voting members unless nominated and appointed as previously described Consultants are held to the same standards for conflict of interest and confidentiality as voting members of the IBC

B Responsibilities of the IBC

 Review all USU research projects that fall under the NIH Guidelines; BSL-2/3

infectious agents, Dual Use Research of Concern (DURC) and ‘Select Agents’

 Review IBC procedures annually

 Review and approve IBC policies in accordance with federal regulations and guidelines and make recommendations to the Vice President on relevant biosafety matters

 Assess containment levels, facilities, procedures, practices, training and expertise of personnel involved in proposed research in accordance with current biosafety standards

 Review and approve SOPs

 Review incidents as reported by the BSO When appropriate assist with an incident investigation and report results to PIs, Deans, Department Heads, and Vice President

 Review and approve reported significant problems or violations to the NIH Office of Science Policy (OSP) as per Section IV-B-2-b-(7) of the NIH

Guidelines, ensuring that the report follows NIH Guidelines for Safety

Reporting found in Appendix M-I-C-4

 Reviews minutes and reports

 Review and maintain approved annual reports to NIH OSP as per Section IV-B-2-b-(7)

 Report results of activities and investigations to the University Safety Committee

 Notify the PI of the results of the IBC review and approval process

 Annual reports to the NIH OSP, as required under Section IV-B-2-a-(3) of the

NIH Guidelines Such reports shall include:

 A roster of all IBC members, indicating the chair, contact person, Biological Safety Officer, plant expert and animal expert, and

 Biographical sketches of all IBC members, including community members

 Report required problems, accidents, illnesses or violations of the NIH Guidelines

to the NIH OSP and to appropriate institutional officials within 30 days Section IV-B-2-b-(7),

 Public comments concerning actions taken by the IBC shall be submitted to the

NIH OSP, along with any institutional response to such comments

 The IBC shall act in an approval and advisory capacity for investigators who wish

to submit Major Actions to the NIH for approval or to undertake research which

is not covered under the NIH Guidelines

C Education of IBC Members

 USU shall ensure appropriate training for the IBC Chair, IBC Vice Chair, BSO and other containment experts (when applicable)

 The IBC Chair and IBC Vice Chair are responsible for ensuring that IBC members are appropriately trained

 The BSO is responsible for ensuring that the PIs have sufficient training

 The PI is responsible for ensuring that laboratory staff are appropriately trained

D IBC Meetings and Reporting

i Agenda

For each scheduled meeting, an “Agenda” shall be provided by the IBC Administrator at least one week prior to the meeting

ii Meetings

Meetings of the IBC shall be held on a regular basis at times and in places

as determined by the Chair of the IBC In general, meetings will be scheduled monthly, but may be cancelled if no new business has been identified for the meeting’s agenda The meeting cannot be conducted until quorum (half plus one) has been established

All IBC meetings shall be open to the public, during discussions of confidential or proprietary information the Chair shall have the right and responsibility to convene closed sessions whenever appropriate, and as

allowed under the NIH Guidelines and state and federal statutes

A record of each scheduled meeting "Minutes" shall be taken in audio format and transcribed in a hard copy, then deleted after approval by the IBC At a minimum the "Minutes" shall include:

1 Date

2 Meeting convening time

3 Location

4 Attendance

5 Why the meeting was opened or closed

6 Major points of discussion

7 Rationale behind decisions

8 Major motions

9 Motion passage or failure

10 Major points of order

11 Meeting adjournment time

Following NIH Guidelines Section IV-B-2-a-(7), USU shall, upon request, make available to the public all IBC meeting minutes and other documents

submitted to or received from federal funding agencies when those agencies

are required to make such documents available

E IBC Review Procedures

 The PI completes protocol registration form (ServiceNow)

 The IBC Administrator reviews the protocol for completeness, then sends

completed form to the IBC Chair (full committee review) or IBC Vice Chair (designated review) to review the proposed protocol

 If the IBC Chair or IBC Vice Chair has questions, then comments will be submitted

to the PI through ServiceNow

 The PI answers the IBC Chair’s or IBC Vice Chair’s questions through ServiceNow

 Once the IBC Chair or IBC Vice Chair is satisfied with the protocol content, the Chair will designate the proposed protocol as

o Exempt

 Research proposals which are exempt from the NIH Guidelines do not

require registration with the IBC However, they may still be required

to follow other federal and state biosafety standards If a change is made to an exempt protocol which may render it no longer exempt

from NIH Guidelines, it must be submitted and approved by the IBC

prior to the PI implementing the changes

o Designated Review

 Research proposals exempt from NIH Guidelines, may receive a designated review where the IBC Vice Chair will designate at least one qualified member of the IBC to review the proposal The Designated Review will suggest to the IBC Vice Chair that the research proposal

be approved, require modifications, or request full committee review

 All IBC members will be given access to the proposal and may request the proposal go before full committee

 Documentation for exempt determinations shall be maintained in IBC records

o Full review

 A convened IBC review of a research proposal shall be required of all

recombinant DNA/nucleic acid registrations, unless exempt from NIH

Guidelines or as specified under "Exempt Determination" In the

review of each research proposal, the IBC shall assess containment levels, facilities, procedures, practices, training and expertise of personnel involved in proposed research in accordance with current biosafety standards

 Updated research proposals originally approved with conditions during full committee review will be returned to an IBC member designated by the IBC Chair for final approval, require clarifications and modifications, or request full committee review All IBC members will have access to the updated proposal Any committee member may request that the updated proposal go before full committee

 The proposed protocol will be to forwarded all committee members through ServiceNow

 The IBC Administratoradds the form to the agenda for the next scheduled IBC meeting

 The IBC Administrator informs the PI the of meeting date, time, and location, inviting them to attend and address any committee questions

 IBC members may review and comment on forms found in ServiceNow prior to any convened meeting

 During convened a IBC meeting, committee members review registrations (new and updated protocols via annual reviews) as listed on the "Meeting Agenda"

 During the review of their protocol, the PI may sit in to address questions by committee members

 Any new comments and/or questions are added to the form on ServiceNow as well as their resolutions

 After review of their form is complete, the PI may leave

 Committee members then deliberate and vote on the research proposal

Committee members may vote to 1) Approve, 2) Approve with conditional changes, or 3) Deny approval

 If approved, the IBC Administrator emails an "Approval Letter" to the PI and all committee members The Administrator uploads the "Approval Letter" to ServiceNow for record purposes

 The "Approval Letter" shall contain:

 Researcher Name

 IBC convened meeting date

 Research activity name

 Notice of research activity approval

 Notice of biosafety level to be used

 Reminder that if any changes are made to the protocol, the Chair must be notified

 If approved with conditional changes, the IBC Chair designates at least one qualified committee member to review the proposal once the changes are made The IBC Chair then sends the form back to the PI to further clarify questions Any changes made to the proposal must be made available to all committee

members If any committee member feels the proposal should go before full committee again, then its review must be deferred until the next convened IBC meeting

 Once the IBC Chair and Designated Reviewer are satisfied with the protocol content, then the protocol is approved and the Administrator sends an approval letter to the PI The Administrator uploads the "Approval Letter" to ServiceNow for record purposes

F Annual Review

 The IBC Administrator sends out an email reminder in July to all PIs with active registrations to complete an Annual Review form via ServiceNow If an Annual Review is not received after one month the IBC Administrator will send out a second email reminder, followed by a third email reminder two weeks later if

necessary

 The PI completes the Annual Review form for an approved research protocol

 The IBC Administrator reviews the form for completion

 The IBC Chair checks form for content

o No changes to the approved research protocol